1-Dodecene, polymer with 1-decene and 1-octene, hydrogenated

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure

DNEL related information

Additional information - workers

Poly alpha olefins and their respective structural analogues were not acutely toxic when administered via oral or dermal routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral or dermal toxicants as defined by EU DSD/DPD 67/548/EEC or CLP EU Regulation 1272/2008 (GHS aligned) criteria; therefore DNELs were not derived for these endpoints.

 

The available acute inhalation toxicity data indicate that some poly alpha olefins (viscosity <15 cSt at 40 ° C, average carbon number <C-30) are acutely toxic in experimental animal studies with inhalation LC50 values consistent with EU labelling requirements for Xn/R20 (Directive 67/548 EEC) or Acute Tox. 4, H332 (Regulation 1272/2008); a DNEL is required for substances meeting these physico-chemical criteria or where experimental data indicate a LC50 below 5 mg/L. However test data available for other samples with kinematic viscosity >15 cSt at 40 °C and an average C-number of 30 or higher return LC50 values in excess of 5 mg/L; no classification or DNEL is required for these substances.

Based on read-across to 1-dodecene polymer with 1-decene, hydrogenated (structural analogue for Alkane 5 with reported LC50 value > 5.0 mg/L), 1-dodecene, polymer with 1-decene and 1-octene, hydrogenated does not require classification for acute inhalation toxicity as defined by EU Dangerous Substance Directive 67/548/EEC or CLP Regulation 1272/2008 (GHS aligned); therefore no DNEL is required.  

Regulatory classification and labeling for aspiration toxicity relies on the measured or calculated kinematic viscosity of a substance at 40°C rather than results from toxicological studies with animals.There are no viscosity data available for 1-dodecene, polymer with 1-decene and 1-octene, hydrogenated. However, read-across viscosity data was available for 1-dodecene polymer with 1-decene, hydrogenated. The reported kinematic viscosity value for 1-dodecene polymer with 1-decene, hydrogenated is 15-20 cSt (Exxon Mobil, 2010). This value exceeds the discriminating threshold for classification for aspiration hazard (<7 cSt) under the DSD but meets the criteria for classification as a Category 1 aspiration hazard under CLP (< 20.5 cSt). Based on the read-across strategy used for poly alpha olefins, it is therefore inferred that 1-dodecene, polymer with 1-decene and 1-octene, hydrogenated is classified as a Category 1 aspiration hazard, H304: (May be fatal if swallowed and enters airway) in accordance with CLP Regulation 1272/2008 (GHS aligned). A DNEL is neither feasible nor appropriate for this endpoint

 

A one-generation reproductive toxicity study in which Alkane 4 (a structural analogue to 1-decene trimer, hydrogenated and tetramers) was administered via oral gavage to rats showed no adverse effects on fertility or development at the highest dose tested of 1000 mg/kg bw/day (Knox et al., 2007). Additionally, rats exposed to Ethylflo 166 (1-decene homopolymer hydrogenated) in utero were again treated with Ethyflo 166 for an additional 91 days beginning 22 days after birth (Daniel, 1994). There were no treatment-related effects reported at the highest dose tested (1000 mg/kg bw/day) in the parental generation, offspring at birth, or following 91 days of subsequent oral exposure. The weight of evidence presented by these studies suggests that poly alpha olefins, as a group, are unlikely to present a significant hazard potential to fertility and development; therefore no DNEL for reproductive toxicity is necessary. 

 

Workers

 

A worker-DNEL_{long-term for dermal route-systemic} and worker-DNEL_{long term for inhalation route-systemic} were not derived for poly alpha olefins because no adverse findings relevant to human health risk assessment were found in several, good quality, high reliability repeated dose studies with these substances at doses at or exceeding a limit dose of 1000 mg/kg bw/day (Daniel, 1994, Cooper, 1995, and Knox et al., 2007). These results indicate that poly alpha olefins, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of DNELs is unnecessary. A worker-DNEL_{long-term for oral route-systemic} was not calculated for poly alpha olefins because oral exposure to these substances was not considered a relevant route of exposure for a worker population based on ‘normal’ use of these substances in a workplace setting.

 

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure

DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure

DNEL related information

Additional information - General Population

General Population

 

General population DNELs for acute effects were not derived because no relevant hazard was apparent from the available toxicological data.

 

A general population-DNEL_{long-term for oral route-systemic}, general population-DNEL_{long-term for dermal route-systemic}, and general population-DNEL_{long term for inhalation route-systemic}were not derived for poly alpha olefins because no adverse findings relevant to human health risk assessment were found in several, good quality, high reliability repeat dose studies with these substances at doses at or exceeding a limit dose of 1000 mg/kg bw/day (Daniel, 1994, Cooper, 1995, and Knox et al., 2007). These results indicate that poly alpha olefins, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of DNELs is unnecessary.